Recall Z-0939-2013— Draeger Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Draeger Medical, Inc., initiated 2012-12-13, terminated 2013-05-20. It names 2 FDA 510(k) clearances: K113798, K093788. Product: Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.. Reason: The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-13
- Terminated
- 2013-05-20
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
- K093788 — INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Reason for recall
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.